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The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy

Primary Purpose

Food Allergy, Food Allergy in Infants, Food Allergy in Children

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Basophil activation test (BAT)
Oral food challenge (OFC)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy focused on measuring Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Mast cell activation test, Diagnosis, Specific IgE, Skin prick test, Oral food challenge

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children and young people aged 6 months to 15 years

  • Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as:

    • history of clinical reaction or
    • evidence of IgE sensitisation (SPT>0mm and/or specific IgE>=0.10 KU/L) to the respective food or
    • reassessment for possible resolution of allergy to the specific food following previous diagnosis of food allergy
  • Need for an oral food challengeOFC to the study food
  • Oral food challengeOFC to reach amount of food protein in a typical portion size for child's age
  • Consent from adults with parental responsibility and assent from children and young people in an age appropriate form.

Exclusion Criteria:

  • Clinically significant chronic illness other than atopic diseases;
  • Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care;
  • Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;

  • Contra-indication for diagnostic food challenge, namely:

    • Uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis);
    • Chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis);
    • Inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, NSAIDs, ACE inhibitor, antacids);
    • Recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants;
  • Undergoing treatment with omalizumab, food or inhalant allergen immunotherapy or other systemic immunomodulatory treatment;
  • Inability to stop anti-histamines prior to SPT or OFC.

Sites / Locations

  • Sandwell and West Birmingham HospitalRecruiting
  • Addenbrookes Hospital
  • Royal Hospital for Children and Young People
  • Leicester Royal InfirmaryRecruiting
  • Evelina London Children's HospitalRecruiting
  • King's College Hospital
  • University College London Hospital
  • Royal Manchester Children's Hospital
  • Great North Children's Hospital
  • Sheffield Children's Hospital
  • University Hospital SouthamptonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biomarker arm

Standard-of-care arm

Arm Description

All participants will have blood taken to test for BAT/MAT. Participants with a positive BAT/MAT will dispense from oral food challenge (OFC). Participants with negative or inconclusive BAT/MAT will undergo OFC.

All participants in the standard-of-care arm will have blood taken to test for BAT/MAT. Regardless of the result of BAT/MAT, all participants in this arm will undergo an oral food challenge, as per the current standard-of-care.

Outcomes

Primary Outcome Measures

The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.
Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.

Secondary Outcome Measures

The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.
Change in quality of life score at the start and end of diagnostic work-up.
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
Change in anxiety score before and after diagnostic work-up.
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
Change in anxiety score before and after diagnostic work-up.
NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.

Full Information

First Posted
September 7, 2021
Last Updated
September 5, 2023
Sponsor
King's College London
Collaborators
Sandwell & West Birmingham Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, NHS Lothian, University Hospitals, Leicester, Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, King's College Hospital NHS Trust, Manchester University NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05309772
Brief Title
The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
Official Title
Randomised Controlled Multicentre Trial on the Clinical Impact of the Basophil Activation Test and the Mast Cell Activation Test as Food Allergy Biomarkers in Children and Young People
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Sandwell & West Birmingham Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, NHS Lothian, University Hospitals, Leicester, Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, King's College Hospital NHS Trust, Manchester University NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.
Detailed Description
Children aged 6 months to 15 years requiring an oral food challenge to one of the study foods (milk, egg, peanut, sesame or cashew nut) will be invited to participate in the study. Eleven centres across the UK will be recruiting participants and perforning clinical procedures, such as skin prick testing and oral food challenges (OFC), as per standard clinical care. Participants will be randomised 4:5 to either have the standard-of-care, i.e. oral food challenge to the suspected food, or take BAT (MAT if BAT inconclusive) into account to decide whether or not OFC will be required: if BAT/MAT is positive, food allergy will be confirmed without doing OFC; if BAT/MAT is negative, participants in the biomarker arm will undergo OFC. The primary outcome is the proportion of positive OFC in the biomarker arm compared with the standard-of-care arm. Secondary outcomes are: number of OFC, quality of life, anxiety and costs associated with the diagnostic work-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Food Allergy in Infants, Food Allergy in Children, Food Allergen Sensitisation, Milk Allergy, Egg Allergy, Nut Allergy
Keywords
Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Mast cell activation test, Diagnosis, Specific IgE, Skin prick test, Oral food challenge

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised using a 4:5 allocation between standard-of-care/biomarker arms. Stratified randomisation will be adopted according to recruiting centre, using a web-based allocation system.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
398 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biomarker arm
Arm Type
Experimental
Arm Description
All participants will have blood taken to test for BAT/MAT. Participants with a positive BAT/MAT will dispense from oral food challenge (OFC). Participants with negative or inconclusive BAT/MAT will undergo OFC.
Arm Title
Standard-of-care arm
Arm Type
Active Comparator
Arm Description
All participants in the standard-of-care arm will have blood taken to test for BAT/MAT. Regardless of the result of BAT/MAT, all participants in this arm will undergo an oral food challenge, as per the current standard-of-care.
Intervention Type
Diagnostic Test
Intervention Name(s)
Basophil activation test (BAT)
Other Intervention Name(s)
Mast cell activation test (MAT)
Intervention Description
Basophils and mast cells are the key drivers of food allergic reactions and anaphylaxis to foods. The study team have developed new tests that measure the reaction of mast cells and basophils by flow cytometry following stimulation with allergen, the BAT and the MAT: • BAT uses fresh whole blood from patients added to allergen and antibodies in a test tube. The tube containing the allergic cells are then analysed one by one to estimate how many and how much express activation markers on their surface, CD63 and CD203c. MAT uses a human mast cell line (LAD2 cells) which are human mast cells grown in the laboratory to which patients' plasma is added in order to mimic the patients' own mast cells. Sensitised LAD2 cells are then stimulated with allergen or controls and analysed by flow cytometry to assess the expression of the activation marker CD63 on the cell surface, similar to what happens in the BAT. Results of MAT will be considered only in cases of non-responding basophils.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral food challenge (OFC)
Intervention Description
Consumption of the food suspected of causing an allergic reaction in a medically supervised environment, starting with small amounts and progressively increasing the dose at regular intervals up to a cumulative dose corresponding to an age-appropriate portion of the food.
Primary Outcome Measure Information:
Title
The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Description
Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.
Time Frame
Up to 1 year
Title
Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Description
Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.
Description
Change in quality of life score at the start and end of diagnostic work-up.
Time Frame
Up to 1.5 years
Title
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
Description
Change in anxiety score before and after diagnostic work-up.
Time Frame
Up to 1.5 years
Title
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
Description
Change in anxiety score before and after diagnostic work-up.
Time Frame
Up to 1.5 years
Title
NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
Description
NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.
Time Frame
Up to 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children and young people aged 6 months to 15 years Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as: history of clinical reaction or evidence of IgE sensitisation (SPT>0mm and/or specific IgE>=0.10 KU/L) to the respective food or reassessment for possible resolution of allergy to the specific food following previous diagnosis of food allergy Need for an oral food challengeOFC to the study food Oral food challengeOFC to reach amount of food protein in a typical portion size for child's age Consent from adults with parental responsibility and assent from children and young people in an age appropriate form. Exclusion Criteria: Clinically significant chronic illness other than atopic diseases; Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care; Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge; Contra-indication for diagnostic food challenge, namely: Uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis); Chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis); Inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, NSAIDs, ACE inhibitor, antacids); Recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants; Undergoing treatment with omalizumab, food or inhalant allergen immunotherapy or other systemic immunomodulatory treatment; Inability to stop anti-histamines prior to SPT or OFC.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Santos, MD, PhD
Phone
+44 (0) 20 7188 6424
Email
alexandra.santos@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Santos, MD, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandwell and West Birmingham Hospital
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Hospital for Children and Young People
City
Edinburgh
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Evelina London Children's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Alexandra Santos
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Manchester Children's Hospital
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Great North Children's Hospital
City
Newcastle
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Sheffield Children's Hospital
City
Sheffield
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy

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